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Clinical DevelopmentClinical Development

Pre-clinical trials

The Institute of Applied Medicine, Inc., a CMIC Group company, provides high-quality CMC services and has experience conducting NDA trials in the United States. The company was graded "A" for its observation of GLP standards, and offers the microanalysis capabilities of LC/MS/MS technology.

Characteristics

Advanced technological capabilities allow the Institute to deliver reliable, high-quality data at low cost and on time.

  • The Institute was the first company in the physical and chemical analysis industry to conduct trials for a new drug application (NDA) to the FDA in the United States on behalf of a client. It currently performs a large number of similar trials on behalf of major pharmaceutical manufacturers.
  • The Institute has been graded "A" for its observation of GLP standards.
  • The Institute received an "A" in its last inspection in 2003.
  • The Institute offers the microanalysis capabilities of LC/MS/MS technology.
Solutions and Services
CMC-related customer services
Stability Testing
  1. Prescription drugs/OTC
    Acceleration test
    Long-term stability test
    Severe test
    Relative comparative test
  2. Validation for analytical methods
  3. Quality control test(GMP requirements for clinical trial drugs)
  4. Formulation stability test
  5. Drug substance physical and chemical property test
  6. Others
Pharmacokinetic Testing
  1. Pharmacokinetic and concentration analysis for Phase I, II, III and IV trials
  2. Pharmacokinetic and concentration measurement and equivalent analysis for biological equivalent tests
  3. TK / PK measurement
  4. Metabolite and structure prediction
  5. Others
Microbial Testing
  1. Sterility test
  2. Endotoxin test
  3. Microbial limit test
  4. Preservatives effectiveness test(Japanese Pharmacopoeia)
  5. Antibiotic titer test
  6. Others
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